Capnomac Ultima Anesthesia Monitor
FDA 510(k) K923276 · Datex Division Instrumentarium Corp.
510(k) numberK923276
Submission
- Device name
- Capnomac Ultima Anesthesia Monitor
- Applicant
- Datex Division Instrumentarium Corp.
Helsinki, Finland, FI - Received
- July 6, 1992
- Decision date
- July 21, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CBQ – Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1500
- Specialty
- Anesthesiology
Other 510(k)s with product code CBQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040917 | Philips Anesthesia Gas Monitor, Model M1026BCBQ · Special | Philips Medizin Systeme Boeblingen GmbH | 04/29/2004SE |
| K994188 | Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5CBQ · Special | Agilent Technologies, GmbH | 05/19/2000SE |
| K962648 | Ohmeda Model 5330 Anesthetic Agent MonitorCBQ · Traditional | Ohmeda Medical | 01/17/1997SE |
| K931439 | Ohmeda Model 5330 Anesthetic MonitorCBQ · Traditional | Ohmeda Medical | 10/19/1993SE |
| K926451 | Datascope Multinex IICBQ · Traditional | Datascope Corp. | 08/25/1993SE |
| K923433 | AS/3 Anaesthesia Monitoring System Airway ModuleCBQ · Traditional | Instrumentarium Corp. | 07/22/1993SE |
| K922876 | AS/3 Cop ModuleCBQ · Traditional | Datex Division Instrumentarium Corp. | 07/21/1993SE |
| K930303 | Datascope Multinex Id PlusCBQ · Traditional | Datascope Corp. | 06/16/1993SE |
| K914295 | Anesthetic Gas Monitor Type 1304, ModifiedCBQ · Traditional | Bruel & Kjaer | 04/10/1992SE |
| K911644 | NGM FrameCBQ · Traditional | Datex Division Instrumentarium Corp. | 03/04/1992SE |
More from Datex Division Instrumentarium Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K953175 | AS/3 Estpr ModuleMLD · Traditional | 02/06/1997SE |
| K961247 | AS/3 Light MonitorDPS · Traditional | 10/23/1996SE |
| K943458 | AS/3 Airway ModuleCBS · Traditional | 02/14/1995SE |
| K945234 | AS/3 Memory Module, M0MEMBSZ · Traditional | 01/27/1995SE |
| K933156 | Datex AS/3 Patient MonitorDPS · Traditional | 12/30/1994SE |
| K933285 | Datex AS/3 TM Anaesthesia MonitorBSZ · Traditional | 11/14/1994SE |
| K943456 | AS/3 Nellcor Compatible Saturation Moodule, M-NsatDQA · Traditional | 10/17/1994SE |
| K923172 | Anaesthesia Record KeeperBSZ · Traditional | 08/09/1994SE |
| K935477 | AS/3(TM) Anesthesia Monitor Syst Interface BoardCCK · Traditional | 08/01/1994SE |
| K943457 | AS/3 Pressure Temperature Module, M-PtDSK · Traditional | 07/27/1994SE |
Questions and answers
When was Capnomac Ultima Anesthesia Monitor cleared by the FDA?
Capnomac Ultima Anesthesia Monitor (K923276) received a 510(k) decision of Substantially Equivalent on July 21, 1993, 380 days after the submission was received.
What is the product code of K923276?
The FDA product code is CBQ – Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration), a Class II (moderate risk) device regulated under 21 CFR 868.1500.